Sam Brusco, Associate Editor03.08.22
Spinal implant systems maker CoreLink has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for adding its new Fusation anchors to its F3D-C2 cervical stand-alone fusion system. Fusation anchors provide an alternative to traditional fixation screws when screw angulation is difficult due to interfering patient anatomy—for example when the chin or sternum limit access to levels of the cervical spine.
The F3D-C2 stand-alone cervical system features an integrated, zero-step anti-back-out locking tab, and now the porous Fusation anchors in addition to screws.
"This unique technology gives our customers a new way to minimize surgical access when treating the cervical spine and improve their surgical workflow," Jay Bartling, CEO of CoreLink told the press. "It was a challenging design process, but with our world-class engineering and advanced knowledge of additive manufacturing, we succeeded. This is another step in our strategy to bring more devices that can provide simultaneous fusion and fixation to market."
CoreLink’s Mimetic Metal technology emulates natural bone via directional lattice architecture and trabecular pores. CoreLink’s in-vitro studies have shown Mimetic Metal increases osteoblast activity compated to machined solid titanium, PEEK, and HA-PEEK. In-vivo studies demonstrated cortical and cancellous bony ingrowth and on-growth.
The F3D-C2 stand-alone cervical system features an integrated, zero-step anti-back-out locking tab, and now the porous Fusation anchors in addition to screws.
"This unique technology gives our customers a new way to minimize surgical access when treating the cervical spine and improve their surgical workflow," Jay Bartling, CEO of CoreLink told the press. "It was a challenging design process, but with our world-class engineering and advanced knowledge of additive manufacturing, we succeeded. This is another step in our strategy to bring more devices that can provide simultaneous fusion and fixation to market."
CoreLink’s Mimetic Metal technology emulates natural bone via directional lattice architecture and trabecular pores. CoreLink’s in-vitro studies have shown Mimetic Metal increases osteoblast activity compated to machined solid titanium, PEEK, and HA-PEEK. In-vivo studies demonstrated cortical and cancellous bony ingrowth and on-growth.